A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants

Part of paid clinical trials in La Palma, California.

Sponsor
DualityBio Inc.
Study ID
NCT06625671
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • DB-2304 — DRUG
    DB-2304
  • Placebo — DRUG
    Placebo
  • Prednisone — DRUG
    Prednisone

Study Details

A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus

Key Dates

Start date
Oct 4, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
  • Experimental: Dose Level 2
  • Experimental: Dose Level 3
  • Experimental: Dose Level 4
  • Experimental: Dose Level 5
  • Experimental: Dose Level 6
  • Experimental: Dose Level 7
  • Experimental: Dose Level 8

Primary Outcome Measure

TEAEs [ Time Frame: Up to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
US06-0La PalmaCalifornia90623-
US03-0ClearwaterFlorida33765-
US05-0OrlandoFlorida32808-
US08-0SyracuseNew York13210-
US04-0IrvingTexas75061-
US02-0San AntonioTexas78215-

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